Comparative Imaging Assessment of Valvular Heart Disease

NCT04126018 | Recruiting

• 1 other identifier: 19-549
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to compare the various 2D and 3D methods of valvular heart disease quantification (Doppler, PISA, VCA, volumetric method) and strain with cardiac magnetic resonance (CMR) measurements of left and right ventricular systolic function strain and myocardial fibrosis assessment.

Conditions

Valve Heart Disease; Aortic Stenosis; Aortic Regurgitation

Outcome Measures

Primary Outcomes (8)

• Change in MRI Quantified LVEDVi

  10% Change from Baseline - units of measure cc/m2

  6 months

• Change in MRI Quantified LVESVi

  15% Change from Baseline - units of measure cc/m2

  6 months

• Change in MRI Quantified LV Strain

  5% Change from Baseline

  6 months

• Change in MRI LVEF

  5% Change from Baseline

  6 Months

• Change in Kansas City Cardiomyopathy Questionnaire Answers

  Change in quality of life related to heart failure symptoms.

  6 Months

• Change in Physical Activity Questionnaire Answers

  Change in physical activity level due to heart failure symptoms.

  6 Months

• All-cause mortality

  number of patients expired

  6 Months

• Development of class I or IIa indication for valve surgery

  The recommended indications for surgery include: development of symptoms, LV dysfunction (LV end-systolic diameter ≥45 mm or LV ejection fraction ≤60%), and new onset of atrial fibrillation or pulmonary hypertension (systolic pulmonary artery pressure \>50 mm Hg at rest).

  6 Months

Secondary Outcomes (1)

• Accuracy of echocardiography as compared with MRI

  6 Months

Study Arms (4)

Mitral Valve Regurgitation

Patients with moderate or severe (3+ or 4+) mitral valve regurgitation on the basis of prior known clinical history or clinical exam.

Diagnostic Test: MRI with strain measurement; Diagnostic Test: Echocardiography

Aortic Valve Regurgitation

Patients with moderate or severe (3+ or 4+) aortic valve regurgitation on the basis of prior known clinical history or clinical exam.

Diagnostic Test: MRI with strain measurement; Diagnostic Test: Echocardiography

Aortic Stenosis

Patients with moderate or severe (3+ or 4+) aortic stenosis on the basis of prior known clinical history or clinical exam.

Diagnostic Test: MRI with strain measurement; Diagnostic Test: Echocardiography

Patients referred for CRT Implantation

Patients who meet clinical guideline criteria for CRT implantation with EF \< 40%

Diagnostic Test: MRI with strain measurement; Diagnostic Test: Echocardiography

Interventions

Echocardiography DIAGNOSTIC_TEST

Doppler, PISA, VCA, volumetric method as performed during echocardiography

Aortic Stenosis; Aortic Valve Regurgitation; Mitral Valve Regurgitation; Patients referred for CRT Implantation

MRI with strain measurement DIAGNOSTIC_TEST

CMR measurements of left and right ventricular systolic function strain and myocardial fibrosis

Aortic Stenosis; Aortic Valve Regurgitation; Mitral Valve Regurgitation; Patients referred for CRT Implantation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with suspected chronic AS, AR, MR or heart failure with reduced ejection fraction being evaluated for CRT implantation referred for clinically indicated CMR and echocardiography by their cardiologists.. CMR and echocardiography will be clinically indicated in this study group.

You may qualify if:

• Age 18-90 years of age
• Suspected moderate or severe MR,AR or AS on the basis of prior known clinical history or clinical exam.
• Suspected CRT "non-responder" with an implanted MRI compatible CRT device and reduced ejection fraction

You may not qualify if:

• Acute traumatic cardiac injury
• Aortic dissection or aortic root rupture
• Congenital heart diseases such as patent ductus arteriosus, coarctation of aorta, ASD and VSD
• Presence of A-V fistula or intracardiac shunts
• Any contraindications to CMR
• Moderate or severe dysfunction in multiple valves
• Patients with significant claustrophobia

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

As part of an optional sub study, subjects will be asked to provide blood samples at the baseline visit. Up to 5 tablespoons (75ml) of blood will be drawn. Genomic analyses will be run on the samples to look for biomarkers which may correlate with the development of myocardial fibrosis.

MeSH Terms

Conditions

Heart Valve Diseases; Aortic Valve Stenosis; Aortic Valve Insufficiency

Interventions

Magnetic Resonance Imaging; Echocardiography

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Cardiac Imaging Techniques; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Deborah Kwon, M. D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deborah Kwon, M. D.

CONTACT

216-444-8526; kwond@ccf.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 20, 2019
• First Posted: October 14, 2019
• Study Start: August 23, 2019
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)